e-SMART/EST HIV Telehealth Intervention

NCT05278572 | Completed

• 1 other identifier: 2021-13391
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to adapt an evidence-based, enhanced cognitive-behavioral stress management intervention (CSBM+) to target depression among older HIV-positive women in the Bronx, New York. The intervention, "Stress Management and Relaxation Training/Expressive Supportive Therapy" (SMART/EST), demonstrated effectiveness in numerous iterations over 15+ years, including trials with racially diverse HIV-positive women. To meet changing community needs including moving behavioral interventions to telehealth, we will pilot test e-SMART/EST, a teletherapy adaptation with peer support for HIV+ older women.

Conditions

Hiv; Depression

Outcome Measures

Primary Outcomes (2)

• Decrease in score from Baseline in Depression on 21-item Beck Depression Inventory (BDI) at Week 9

  The Beck Depression Inventory (BDI) is a validated, self-report 21-item scale assessing depression. Response options range from 0-3 for each item. Item scores are summed, with sum scores ranging from 0-63. Higher scores indicate more depression (i.e., worse outcome). Scale scores from 1-10 indicate: These ups and downs are considered normal; 11-16: Mild mood disturbance; 17-20: Borderline clinical depression; 21-30: Moderate depression; 31-40: Severe depression; over 40: Extreme depression.

  Baseline and Week 9

• Decrease in score from Baseline in Anxiety on 21-item Beck Anxiety Inventory (BAI) at Week 9

  The Beck Anxiety Inventory (BAI) is a validated, self-report 21-item scale assessing anxiety. Response options range from 0-3 for each item. Item scores are summed, with sum scores ranging from 0-63. Higher scores indicate more anxiety (i.e., worse outcome). Scale scores from 0-21 indicate: low anxiety; 22-35: moderate anxiety; 36 and above: potentially concerning levels of anxiety.

  Baseline and Week 9

Study Arms (1)

Group

EXPERIMENTAL

Intervention consists of a psychotherapy trial using cognitive-behavioral stress management/expressive supportive therapy to target depression among HIV-positive older women. Dosage: 8 sessions. Frequency: weekly. Duration: 8 weeks.

Behavioral: Stress Management and Relaxation Training/Expressive Supportive Therapy (SMART/EST)

Interventions

Stress Management and Relaxation Training/Expressive Supportive Therapy (SMART/EST) BEHAVIORAL

Cognitive-behavioral stress management/expressive supportive therapy (CBSM+) group targeting depression

Group

Eligibility Criteria

• Age: 55 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-positive
• Age 55+
• Teletherapy access
• Depression in last 12 months.
• Fluent in English

You may not qualify if:

• HIV-negative or HIV-unknown
• Younger than 55 years old
• Lack of depression in last 12 months
• Non-fluent in English
• Opioid use disorder in last 12 months
• Psychotic disorder in last 12 months.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Albert Einstein College of Medicine - Department of Psychiatry and Behavioral Sciences

The Bronx, New York, 10461, United States

Location

Related Publications (9)

• Waldron EM, Burnett-Zeigler I, Wee V, Ng YW, Koenig LJ, Pederson AB, Tomaszewski E, Miller ES. Mental Health in Women Living With HIV: The Unique and Unmet Needs. J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:2325958220985665. doi: 10.1177/2325958220985665.

  PMID: 33472517 BACKGROUND

• Jones DL, McPherson-Baker S, Lydston D, Camille J, Brondolo E, Tobin JN, Weiss SM. Efficacy of a group medication adherence intervention among HIV positive women: the SMART/EST Women's Project. AIDS Behav. 2007 Jan;11(1):79-86. doi: 10.1007/s10461-006-9165-8.

  PMID: 17028992 RESULT

• Weiss SM, Tobin JN, Antoni M, Ironson G, Ishii M, Vaughn A, Cassells A, Jones D, Schneiderman N, Brondolo E, Laperriere A, Lopez M, Villar-Loubet O, Camille J, Kumar M, Page JB; SMART/EST Women's Project Team*. Enhancing the health of women living with HIV: the SMART/EST Women's Project. Int J Womens Health. 2011 Feb 15;3:63-77. doi: 10.2147/IJWH.S5947.

  PMID: 21445376 RESULT

• Laperriere A, Ironson GH, Antoni MH, Pomm H, Jones D, Ishii M, Lydston D, Lawrence P, Grossman A, Brondolo E, Cassells A, Tobin JN, Schneiderman N, Weiss SM. Decreased depression up to one year following CBSM+ intervention in depressed women with AIDS: the smart/EST women's project. J Health Psychol. 2005 Mar;10(2):223-31. doi: 10.1177/1359105305049772.

  PMID: 15723892 RESULT

• Ironson G, Weiss S, Lydston D, Ishii M, Jones D, Asthana D, Tobin J, Lechner S, Laperriere A, Schneiderman N, Antoni M. The impact of improved self-efficacy on HIV viral load and distress in culturally diverse women living with AIDS: the SMART/EST Women's Project. AIDS Care. 2005 Feb;17(2):222-36. doi: 10.1080/09540120512331326365.

  PMID: 15763716 RESULT

• Segal-Isaacson CJ, Tobin JN, Weiss SM, Brondolo E, Vaughn A, Wang C, Camille J, Gousse Y, Ishii M, Jones D, Laperriere A, Lydston D, Schneiderman N, Ironson G. Improving dietary habits in disadvantaged women with HIV/AIDS: the SMART/EST women's project. AIDS Behav. 2006 Nov;10(6):659-70. doi: 10.1007/s10461-006-9115-5. Epub 2006 Jun 1.

  PMID: 16770694 RESULT

• Weiss SM, Tobin JN, Lopez M, Simons H, Cook R, Jones DL. Translating an Evidence-Based Behavioral Intervention for Women Living with HIV into Clinical Practice: The SMART/EST Women's Program. Int J Behav Med. 2015 Jun;22(3):415-24. doi: 10.1007/s12529-014-9399-1.

  PMID: 24623475 RESULT

• Jones DL, Lopez M, Simons H, Diaz-Gloster M, Tobin JN, Weiss SM. Translation of a comprehensive health behavior intervention for women living with HIV: the SMART/EST Women's Program. Transl Behav Med. 2013 Dec;3(4):416-25. doi: 10.1007/s13142-013-0213-4.

  PMID: 24294330 RESULT

• Webel AR. Testing a peer-based symptom management intervention for women living with HIV/AIDS. AIDS Care. 2010 Sep;22(9):1029-40. doi: 10.1080/09540120903214389.

  PMID: 20146111 RESULT

Related Links

• Clinical Directors Network website for previous iterations of the SMART/EST group for HIV-positive women

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Depression

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Harris Goldstein, MD

  Einstein-Rockefeller-City University of New York Center for AIDS Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: N/A: Study only has one arm.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This clinical trial involves a single treatment arm, consisting of 10 women enrolled in a pilot group. The group will meet weekly for 8 weeks. The intervention consists of cognitive-behavioral stress management/expressive supportive therapy (CBSM+) targeting depression among older women with HIV. The group will be co-facilitated by a Psychologist and a Peer.

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 14, 2022
• Study Start: January 25, 2023
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)